# K972675: CO2 Gas Warming Unit (6-800-00)

- Pathway: 510(k) (Traditional)
- Applicant: Northgate Technologies, Inc.
- Decided: Sep 30, 1998 after 441 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
THE NORTECH GAS WARMING UNIT IS INDICATED FOR WARMING GAS (95-106°F / 35-41°C) USED FOR THE DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND / OR OPERATIVE LAPAROSCOPY.

Source page: https://510kreport.com/device/K972675
Methodology: https://510kreport.com/methodology